Medical apparatus and method of making the same

ABSTRACT

A hemostatic valve apparatus used in medical procedures that provides rapid activation of a sealing mechanism resulting in lower blood loss during use of the sealing device. The valve apparatus incorporates an actuator and two mechanisms that counter-rotate opposite ends of a sealing tube.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a valve for use in medical applications, morepreferably a hemostasis valve apparatus used in medical procedures.

2. Background

Hemostatic valves are used in a wide variety of minimally invasive andconventional surgical procedures. For example, laparoscopic andarthroscopic surgical procedures are often performed through trocar orintroducer assemblies which include hemostatic valves. After a trocar orintroducer sheath is inserted to provide access to a body target site,surgical instruments, tools, guidewires, implantable devices ordiagnostic instruments are inserted into and withdrawn from a hemostaticsealing valve located at a proximal end of the trocar or introducer. Thehemostatic valve generally prevents fluid from inadvertently leaving orentering the body target site through the trocar or introducer. Asadvanced surgical procedures have emerged, hemostatic valves have facedmore stringent demands. For example, a wider range of device profilesand a greater number of devices are often passed through a singlehemostatic valve.

Current hemostatic valves generally fall into two basic categories:passive and active. To form the desired fluid tight seal, a passivevalve generally relies on a resilient sealing body being deformed by thedevice as it is inserted through the valve. An active valve includes ameans to move a sealing body into contact with the traversing device.

A wide variety of active and passive hemostatic valves have beenproposed. While these structures have met with varying degrees ofsuccess and acceptance, they generally have suffered from commondisadvantages. For example sealing bodies (whether passive or active)which seal effectively over a wide range of device cross-sectionalprofiles tend to impose excess friction on at least some sizes oftraversing devices. Active devices which seal effectively over a widerange of device cross-sectional profiles have the disadvantage ofrequiring extended actuation travel (i.e. thumb or finger motion) alongwith excessive time to fully open and close the sealing device.

It would be desirable to provide an improved hemostatic valve for use inendovascular, laparoscopic and other surgical procedures. Such a valveshould preferably seal over a wide range of device sizes,cross-sectional profiles and lengths without imposing excess frictiononto the device. In addition, such a valve should preferably be actuatedwith a finger or thumb motion and be able to be fully opened or closedin a minimal amount of time and without requiring extended actuationtravel.

SUMMARY OF THE INVENTION

Accordingly, the invention comprises a hemostatic valve apparatus usedin medical procedures that substantially obviates one or more of theproblems due to limitations and disadvantages of the related art.

The instant invention comprises a counter rotating hemostatic valve. Inone embodiment, the invention comprises an apparatus comprising aflexible sealing tube, a first mechanism attached to said flexiblesealing tube, a second mechanism attached to said flexible sealing tubeand an actuator coupled to the first and second mechanisms, wherein theactuator is capable of counter rotating the first and second mechanisms.In another embodiment, said apparatus is a vascular introducer sheath.In another embodiment, said flexible sealing tube has a proximal end, adistal end, and the first rotation mechanism is attached to a distal endof said sealing tube. In another embodiment the first and secondmechanisms are attached to opposite ends of said flexible sealing tube.When the first and second mechanisms are counter rotated, said flexiblesealing tube is twisted causing said tube to collapse and create a leakproof seal around a device within the tube. It is also contemplated thata leak proof seal can be formed even if no devices are in the flexiblesealing tube when the sealing tube is twisted.

The invention also comprises a valve for effecting selective closure ofa catheter lumen to control fluid flow through said catheter lumen,comprising, a flexible sealing tube having a lumen extending from aproximal end to a distal end, a first rotation mechanism attached to thetube, wherein the first rotation mechanism comprises a first gear, asecond rotation mechanism attached to the flexible sealing tube, whereinthe second rotation mechanism comprises a second gear, and an actuatorcoupled to the first and second rotation mechanisms, wherein theactuator is capable of counter rotating the first and second rotationmechanisms.

An advantage of the present invention is to provide faster activation ofthe sealing mechanism. Other advantages of the present invention are toprovide lower blood loss during the activation of the sealing device andto provide an intuitive and easy to use activation mechanism.

Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be apparent from thedescription, or may be learned by practice of the invention. Theobjectives and other advantages of the invention will be realized andattained by the structure particularly pointed out in the writtendescription and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description serve to explain the principles of theinvention.

In the drawings:

FIG. 1A is a perspective view of a hemostatic valve assembly accordingto a configuration of the present invention.

FIG. 1B is a magnified perspective view of the housing previously shownin FIG. 1A.

FIG. 1C is a perspective cut-away view of a valve mechanism according toa configuration of the present invention.

FIG. 1D is a perspective cut-away view of a valve mechanism according toa configuration of the present invention.

FIG. 2 is a perspective view of an alternate actuation mechanismsuitable for use as a valve mechanism.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The invention relates to a valve apparatus for use in medicalapplications, more preferably a hemostatic valve apparatus used inmedical procedures. The medical procedures may be a laparoscopic,endoscopic, and other medical procedures.

Reference will now be made in detail to an embodiment of the presentinvention, examples of which are illustrated in the accompanyingdrawings.

Referring to FIG. 1A, an apparatus according to an embodiment of theinvention is generally depicted as reference number 100. The apparatus100 includes a housing 102 and a sheath 104 connected to the housing102. Sheath 104 may be manufactured of either fluorinated ethylenepropylene (FEP) or extruded high density polyethylene or any othermaterial with suitable biocompatible and mechanical properties. One ofskill in the art can readily appreciate that there are a wide variety ofpotential materials that can be used to facilitate the presentinvention. Sheath 104 may be of any size. In one embodiment, sheath 104is from about 12 to about 26 Fr. The proximal most end of the sheath 104may comprise a flange that will keep sheath 104 from slidinglongitudinally within housing 102 (105 FIG. 1D). Sheath 104 may beattached to housing 102 in a variety of ways. In one embodiment, sheath104 may be attached to the housing 102 by using adhesives such aspolyurethane adhesives, quick setting cyanoacrylate adhesives orultraviolet cure adhesives. In another embodiment, sheath 104 isattached to housing 102 by ultrasonic welding, interference fit, thermalbond, insert molding or a combination thereof. One of skill in the artcan readily appreciate that there are a wide variety of potential meansfor attaching sheath 104 to housing 102. Said attachment of sheath 104to housing 102 will create a leak proof attachment. For the purposes ofthis invention, the terms “leak proof attachment” and “leak proof seal”means that either no fluids or an insignificant amount of fluids willleak from said attachment or seal when used in surgical orinterventional procedures.

Housing 102 may be of an ergonomic design to facilitate use. An actuator106 is partially covered with housing 102. Housing 102 includes aproximal end 108 and distal end 110. The proximal end 108 is configuredto include a proximal valve (not shown). Housing 102 can be constructedout of polymethyl methacrylate (PMMA or Acrylic), polystyrene (PS),acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC),modified polyethylene terephthalate glycol (PETG), cellulose acetatebutyrate (CAB), polyethylene (PE), high density polyethylene (HDPE), lowdensity polyethylene (LDPE or LLDPE), polypropylene (PP), polycarbonate(PC), modified polyphenylene oxide (Mod PPO), polyphenelyne ether(PPE),thermoplastic polyurethane (TPU), polyamide (PA or Nylon),polyoxymethylene (POM or Acetal), polyethylene terephthalate (PET,Thermoplastic Polyester), polybutylene terephthalate (PBT, thermoplasticpolyester), ultra high molecular weight polyethylene (UHMW-PE),fluorinated ethylene propylene (FEP), or any other medical grade polymercommonly known in the art.

In another embodiment, housing 102 is comprised of two halves that arejoined together to form housing 102 and may enclose a number ofcomponents, as described below. Said two halves of housing 102 can bejoined together by adhesives, any method described above or method knownin the art.

FIG. 1B depicts a perspective view of the housing 102 shown in FIG. 1A.In one embodiment, housing can be configured to allow a user to graspsaid housing with one hand. Portions of actuator 106 are exposed throughan opening in the housing allowing the user to rotate the actuator 106in the directions shown by arrows 107. In one embodiment, the actuatorcan be rotated about 180° or less. In another embodiment, the actuatorcan be rotated to a maximum of about 360°. Internal to the housing aretwo mechanisms that are driven by the rotation of the actuator. The twomechanisms are attached to opposite ends of a flexible sealing tube (asdescribed below). Rotation of the actuator 106 causes the two mechanismsto “counter rotate” and twist the sealing tube ends in oppositedirections. The twisting of the sealing tube causes the tube to collapsearound a device that is inserted into the housing, in the direction asindicated by arrow 109, to create a leak proof seal. In one embodiment,said actuator is attached to said first and second mechanism via a gear.Said gear can be selected from the group consisting of a spur gear,helical gear, bevel gear, worm gear, and combinations thereof. Shown inFIG. 1B is an optional ergonomic user interface feature 118 locatedalong at least a portion of the actuator 106 outer surface. Ergonomicfeature 118 can help user grip actuator 106 for easy turning. In oneembodiment, said actuator can be turned using operator's hand. Inanother embodiment, said actuator can be turned using only a thumb or athumb and forefinger. Once the leak proof seal is made, the medicalapparatus or actuator may have a means of keeping said actuator in placeto maintain said leak proof seal. In one embodiment, said means is alatch. Other means include spring loaded detents, locking screws,locking cams or frictional interference fits.

Also shown in FIG. 1B is an optional flushing port 105. The function anduse of flushing port 105 and fitting are commonly known in the art.

FIG. 1C illustrates a cross-sectional view of FIG. 1B along line I toI′.

The actuator 106 is used to rotate a first mechanism 112 and counterrotate a second mechanism 114. In one embodiment, the actuator 106includes a beveled gear portion 116 on at least a portion of itscircumference and an optional ergonomic user interface feature 118. Thefirst mechanism includes a beveled gear portion 120 and the secondmechanism includes a beveled gear portion 122 on their respectivecircumferences. The first mechanism is attached to a distal portion offlexible sealing tube 124 with a coupling agent and the second mechanismis attached to a proximal portion of flexible sealing tube 124 withanother coupling agent to make a leak proof attachment. In anotherembodiment, the first mechanism 112 includes a sealing channel 134 forreceiving sealing mechanism 136. The second mechanism 114 also includesa sealing channel 126 for receiving sealing mechanism 128. Sealingmechanisms (128 and 136) can be selected from the group consisting ofO-rings, flexible knife-edge seals, viscous gels or any other systemknown in the art. Sealing mechanisms (128 and 136) provide a rotatablefluid seal between the first/second mechanisms 112,114 and the housing102.

In another embodiment, as depicted in FIGS. 1C and 1D, mechanism 112 isa solid piece that comprises proximal shoulder 150, a distal shoulder152, beveled gear portion 120 on at least a portion of its circumferenceand a lumen in the center of said mechanism so that medical tools, suchas, catheters, sheaths, guidewires, and the like, used in medicalprocedures can pass through mechanism 112. Mechanism 112 can beconstructed out of any biocompatible metal or plastic with suitablebiocompatible and mechanical properties. For example polymethylmethacrylate (PMMA or Acrylic), polystyrene (PS), acrylonitrilebutadiene styrene (ABS), polyvinyl chloride (PVC), modified polyethyleneterephthalate glycol (PETG), cellulose acetate butyrate (CAB),polyethylene (PE), high density polyethylene (HDPE), low densitypolyethylene (LDPE or LLDPE), polypropylene (PP), polycarbonate (PC),modified polyphenylene oxide (Mod PPO), polyphenelyne ether (PPE),thermoplastic polyurethane (TPU), polyamide (PA or Nylon),polyoxymethylene (POM or Acetal), polyethylene terephthalate (PET,Thermoplastic Polyester), polybutylene terephthalate (PBT, ThermoplasticPolyester), ultra high molecular weight polyethylene (UHMW-PE),fluorinated ethylene propylene (FEP), or any other medical grade polymeras commonly known in the art can be used to fabricate mechanism 112 orother components of the apparatus 100.

Proximal shoulder 150 is designed to accept sleeve 154 of the flexiblesealing tube 124 to create a leak proof attachment. The sleeve 154 canbe attached by a mechanical coupling agent, such as a collar, crimpring, snap ring, clamp, combinations thereof, or methods known in theart. In another embodiment, sleeve 154 can be attached by insert moldingor by a biocompatible adhesive, such as a silicone adhesive, urethaneadhesive, cyanoacrylate adhesive, epoxy adhesive or combinationsthereof, or other methods known in the art. Mechanism 112 also comprisesdistal shoulder 152. Distal shoulder 152 may comprise a sealing channel134 for receiving a rotatable seal (or other sealing mechanisms) 136.Said rotatable seal can be an O-ring. Other sealing mechanisms compriseflexible knife-edge seals, viscous gels and the like. These mechanismscan be used to form rotatable seals. Said apparatus can further compriseanother sealing mechanism, e.g., elastic diaphragm, compression fitting,cap, second tube, brushes, inflatable valve, etc.

In one embodiment, distal shoulder 152 will be placed in a cradle moldedinto housing 102. Once the sealing mechanism 136 and sleeve are placedin housing 102, a leak proof attachment, that allows rotation ofmechanism 112, will be formed when housing 102 is assembled. Mechanism112 may also comprise at least one flange 156, which, in one embodiment,prevents mechanism 112 from sliding longitudinally in housing 102 andwill allow rotation of mechanism 112.

Similarly, mechanism 114 comprises proximal shoulder 160, a distalshoulder 158 and beveled gear portion 122 on at least a portion of itscircumference. Proximal shoulder 158 will accept sleeve 154 of theflexible sealing tube 124 to create a leak proof attachment. Sleeve 154is attached to shoulder 158 as described above. Further, mechanism 114comprises proximal shoulder 160 which may comprise a sealing channel 126for receiving sealing mechanism 128. Said sealing mechanism can be anO-ring or any type of sealing mechanism described above. In oneembodiment, proximal shoulder 160 will be placed in a cradle molded intohousing 102. Once the sealing mechanism 128 and sleeve are placed inhousing 102 a leak proof attachment, that allows rotation of mechanism114, will be formed when housing 102 is assembled. Mechanism 114 mayalso comprise at least one flange 156, which, in one embodiment,prevents mechanism 114 from sliding longitudinally in housing 102 andallows rotation of mechanism 114.

The flexible sealing tube 128 is a conduit for passing medical tools(devices), such as, catheters, sheaths, guidewires, and the like, usedin medical procedures. Preferably, the tube is at least a partiallycompressible conduit that enables a fluid seal around a passed device.The tube may be designed to have any number of different geometricallyshaped cross-sections, such as circular, oval, elliptical, diamond,square, polygon, combinations thereof and the like. In addition, thesleeve may narrow along its length, e.g., having a conical shape. Forexample, a cross-section near the sleeve may be larger than across-section at the other end of the tube. Preferably, the tube isdesigned to have a circular cross-section. In addition, the tube mayinclude localized regions of restricted or enlarged cross-sections.

When utilizing a circular cross-section, the inside diameter of theuntwisted tube may be in the range from about 1 mm to about 30 mm ormore. In one embodiment, the inside diameter ranges from about 4 mm toabout 26 mm. In another embodiment, the inside diameter ranges fromabout 4 mm to about 8 mm.

Depending on the material used, the wall thickness of the flexiblesealing tube will depend on the tensile strength of material and ease oftwisting. A person of skill in the art can readily determine therequired wall thickness for an application. In one embodiment, the wallthickness of said flexible sealing tube is from about 0.5 mm to about 2mm.

The length of the flexible sealing tube may vary according to theapplication. In one embodiment, the length of said flexible sealing tubeis from 0.5 cm to about 30 cm. In another embodiment, the length of saidflexible sealing tube is from about 6 cm to about 25 cm. In anotherembodiment, the length of said flexible sealing tube is from about 2 cmto about 10 cm. A person of skill in the art can readily determine therequired length for specific applications.

The flexible sealing tube 124 can be constructed, in whole or in part,utilizing a variety of materials, such as, synthetic materials, naturalmaterials, and combinations thereof. In one embodiment, the flexiblesealing tube can be constructed of an elastic polymer such as silicone,polyurethane, latex or the like. Other suitable tube materials includeexpanded polytetrafluoroethelene (ePTFE), silks, polyester weaves orother medical grade materials. Porous materials can be rendered lesspervious to fluids by filling the tube material voids with an elastomeror other filling agents. The flexible sealing tube can furtherincorporate reinforcement materials or members such as high strengthfibers or ribbons. The flexible sealing tube can also be fabricated fromtwo or more different materials having different mechanical propertiessuch as durometers or degrees of elasticity.

One embodiment of the invention comprises a sealing tube made with atleast two types of material. For the purposes of this invention,different types of materials can be made from the same substance(s) buthave different properties, for example, different durometer orelasticity. Thus, in one embodiment, the flexible sealing tube has a lowdurometer inner material combined with a higher durometer outermaterial. For example a tube can comprise at least two materials havinga difference in durometers of about 10%, about 20%, about 30%, about40%, about 50% or more. The low durometer inner material can morereadily conform to an irregular shape and thus facilitate sealing aroundan inserted device. The higher durometer outer material can support theinner low durometer material and enhance the tear resistance of saidtube. The high durometer material can also increase the compressiveforce imparted onto the device being inserted into a tube. Thedifference in durometer can be attributed to a flexible sealing tubemade with two different materials or with the same material but is madeto have differing durometer, for example by varying the thickness of thematerial.

The flexible sealing tube 124 can also have a difference in durometersalong the length of the tube. For example the tube may have a lowdurometer on one or both ends, combined with a higher durometer portionin the mid-section of the tube. The tube can also be configured in theopposite form with a higher durometer on an end (or ends) of theflexible sealing tube, with a lower durometer portion in the mid-sectionof the tube. The difference in durometers can be about 10%, about 20%,about 30%, about 40%, about 50% or more.

The flexible sealing tube 124 can also have a varying wall thickness.For example the tube can have a thick wall at the end (or ends) of thetube combined with a thinner wall in the mid-section of the tube. Thetube can also be configured in the opposite form with a thin wall on theend (or ends) with a thicker wall in the mid-section. The tube wallthickness can also be “tapered” with a progressive change in wallthickness along the length of the tube. The difference in wall thicknessalong the length of a tube can be about 10%, about 20%, about 30%, about40%, about 50% or more. Combinations of varied durometers, variedmaterials and various wall thicknesses can be incorporated into theflexible sealing tube. Tubes can also have “repeating structures” orrepeating segments joined together. For example the properties of a tubecan vary along the length of a segment and multiple segments can bejoined to form a tube.

The flexible sealing tube can also be “pre-compressed” during assemblyof the valve mechanism. For example a tube having a free, unconstrainedlength of about 4 cm can have a pre-compressed length of about 3 cmafter being assembled into a valve mechanism. Pre-compressing the tubereduces the tube's wall tension as the tube is twisted. Less tension inthe tube wall increases the conformability of the tube, resulting inenhanced sealing around a device. The difference between a freeunconstrained tube length and a pre-compressed tube length can be about3%, about 5%, about 7%, about 10%, about 15%, about 20%, about 25%,about 30% or more.

To aid in the insertion of a medical device into the sealing tube, alubricious material, coating or liner may be incorporated onto the innerdiameter of the tube as commonly known in the art. In additionanti-microbial and/or therapeutic agents can be applied to the sealingtube.

Another embodiment of the invention comprises a valve apparatus, whereinthe valve apparatus comprises: a flexible sealing tube; a firstmechanism attached to flexible sealing tube; a second mechanism attachedto flexible sealing tube; and an actuator coupled to the first andsecond mechanisms, wherein the actuator is capable of counter rotatingthe first and second mechanisms (112 and 114, respectively). In oneembodiment, said valve apparatus is a component of a medical deviceapparatus. In another embodiment, said medical device apparatus is avascular introducer sheath or any device that allows access to apatient's vasculature. Vascular introducer sheaths are well knowncomponents of vascular access systems which are used in a wide varietyof diagnostic and therapeutic vascular procedures, such as angiography,angioplasty, thermolysis, and embolization procedures. Vascular accesssystems typically include an introducer sheath for use in combinationwith a guide wire and a dilator. One important feature of said valve isthat it prevents bodily fluids from escaping through the valve when anintroducer sheath is inserted into a patient's vasculature. Anotherfeature is that when medical tools (devices), such as, catheters,sheaths, guidewires, and the like, used in medical procedures, areinserted into said valve and then closed, as described above, a leakproof seal will be made, thus preventing bodily fluids from leaving thepatient's vasculature or allowing an insignificant amount of bodilyfluids from leaving the patient's vasculature.

Reference will now be made in detail to an embodiment of the presentinvention, example of which is illustrated in the accompanying drawing,FIG. 2.

FIG. 2 illustrates an alternate valve mechanism 200 according to anotherembodiment of the invention. The mechanism shown in FIG. 2 can becontained with a suitable housing (not shown) similar to that shown inFIGS. 1A and 1B. Referring to FIG. 2, a distal end of tube 124 isattached to a first mechanism 202, and the proximal end of tube 124 isattached to second mechanism 204. When actuator 206 is moved in thedirection as depicted by arrow 208, the first and second mechanisms(202, 204) are driven by the linear track gears 210. The mating gearteeth cause the first and second mechanisms (202, 204) to counterrotate, causing the tube 124 to twist and compress upon itself or tocompress upon a device within the tube. Said actuator can be moved byoperator's hand, by a clamp or other methods known in the art.

This invention is further illustrated by the following examples whichshould not be construed as limiting. The contents of all the Figures areincorporated herein by reference.

EXAMPLE 1

A hemostatic valve assembly similar to FIG. 1 was manufactured using thefollowing components and assembly process:

1) Components were fabricated using a rapid prototyping,stereolithography (SLA) process. The parts were fabricated by ProtoCam(Northampton, Pa.) using an SLA material designated as Accura® 25plastic. This material when cured had an advertised tensile strength ofabout 38 Mpa, a tensile modulus of about 1590-1660 Mpa, an elongation tobreak of about 13-20% and a hardness of about 80 Shore D. The tensileand elongation data were derived using test method ASTM D 638. Sevenparts were fabricated using this SLA process and Accura® 25 plasticmaterial. The parts included a top housing, bottom housing, an actuationor wheel bevel gear, two identical bevel gear seals, a proximal hub anda distal hub.

2) Other materials required for the assembly of the hemostatic valvewere purchased items. An elastomeric tube (used for the twist sealingcomponent) having a outer diameter of about 0.4″ (1 cm), a wallthickness of about 0.03″ (0.8 mm) and a length of about 1.3″ (3.3 cm)was procured from Specialty Silicone Fabricators (Paso Robles, Calif.).This tube was formed of an elastomeric silicone having a durometer ofabout 30 A. Two O-rings (used for seals), size −014 of 70 A siliconewere procured from Molding Solutions (Lexington, Ky.). A polycarbonatedowel pin (used as an actuation wheel shaft) having a diameter of about0.25″ (6.4 mm) and a length of about 0.3″ (7.6 mm) was supplied fromin-house stock. An RTV silicone adhesive and a quick set cyanoacrylateadhesive were supplied from in-house stock.

3) The hemostatic valve was then assembled using the componentsdescribed above. The polycarbonate dowel pin was glued into the centerhole of the actuation bevel gear using the quick set cyanoacrylateadhesive. This gear with attached dowel pin was then placed into thebottom housing. The ends of the elastomeric silicone tube were thenglued to the two bevel gear seals using the RTV silicone adhesive. Thetwo O-rings were then placed over the ends of the two bevel gear seals.The proximal and distal hubs were then placed over the ends of the bevelgear seals. The silicone tube with attached bevel gear seals, O-ringsand proximal and distal hubs were then placed onto the actuation bevelgear and into the slots formed into the bottom housing. The top housingwas then placed onto the bottom housing. The top and bottom housingswere then secured together with the quick set cyanoacrylate adhesive,forming a hemostatic valve assembly as depicted in FIG. 1.

4) An optional extended sheath can be added to the distal end of thevalve assembly along with an optional bleed tube and valve.

EXAMPLE 2

The hemostatic valve assembly of EXAMPLE 1 was evaluated to determinethe amount of thumb motion required to fully open the valve startingfrom a fully closed state. For a total thumb motion that extended over a1.3″ length, the sealing element traversed from a fully closed state toa fully opened state having an inner diameter of about 0.34″. Bycomparison an identical tube twisted from only one end should requireabout two times the amount of thumb motion.

It will be apparent to those skilled in the art that variousmodifications and variation can be made in the present invention withoutdeparting from the spirit or scope of the invention. Thus, it isintended that the present invention cover the modifications andvariations of this invention provided they come within the scope of theappended claims and their equivalents.

1. A medical apparatus, comprising: a flexible tube; a first mechanismattached to the tube; a second mechanism attached to the tube; and anactuator coupled to the first and second mechanisms, wherein theactuator is capable of counter rotating the first and second mechanism.2. The apparatus of claim 1, wherein the actuator is coupled to thefirst and second rotation mechanisms with gears.
 3. The apparatus ofclaim 2, wherein said gears are selected from the group consisting of aspur gear, helical gear, bevel gear, worm gear, and combinationsthereof.
 4. The apparatus of claim 1, wherein said medical apparatusprevents the loss of bodily fluids.
 5. The apparatus of claim 1, whereinsaid medical apparatus is a vascular introducer sheath.
 6. The apparatusof claim 1, wherein said medical apparatus further comprises a latch ormeans of holding said actuator in place once said tube is twisted. 7.The apparatus of claim 1, wherein counter rotating the first and secondrotation mechanisms twists said tube and forces said tube to collapsearound at least one medical device inserted into said tube.
 8. Theapparatus of claim 7, wherein said medical device is selected from thegroup consisting of catheters, sheaths, and guidewires.
 9. The apparatusof claim 1, wherein the tube has a substantial circular cross section.10. The apparatus of claim 1, wherein the tube has a polygoncross-section.
 11. The apparatus of claim 1, wherein the tube has aninner diameter of at least 3 mm.
 12. The apparatus of claim 1, whereinthe tube comprises a material selected from the group consisting ofexpanded polytetrafluoroethelene (ePTFE), silks, polyester weaves andporous filled materials.
 13. The apparatus of claim 1, wherein thewherein the tube comprises two or more different materials havingdifferent mechanical properties such as durometers or degrees ofelasticity.
 14. The apparatus of claim 1, further comprising anothersealing mechanism.
 15. The apparatus of claim 14, wherein saidadditional sealing mechanism is selected from the group consisting ofelastic diaphragm, compression fitting, cap, second tube, brushes, andan inflatable valve.
 16. The apparatus of claim 1, wherein the tube hasa length in the range from about 6 to about 25 mm.
 17. The apparatus ofclaim 1, wherein the actuator can be rotated about 180° or less.
 18. Theapparatus of claim 1, wherein the actuator can be rotated to a maximumof about 360°.
 19. A valve for effecting selective closure of a catheterlumen to control fluid flow thorough said catheter lumen, comprising: aflexible tube having a lumen extending from proximal end to a distalend; a first rotation mechanism attached to the tube, wherein the firstrotation mechanism comprises a first gear; a second rotation mechanismattached to the tube, wherein the second rotation mechanism comprises asecond gear; and an actuator coupled to the first and second rotationmechanisms, wherein the actuator is capable of counter rotating thefirst and second rotation mechanisms.
 20. The valve of claim 19, whereinthe first and second gears are selected from the group consisting of aspur gear, helical gear, bevel gear, worm gear, and combinationsthereof.
 21. The valve of claim 19, wherein the tube comprises amaterial selected from the group consisting of expandedpolytetrafluoroethelene (ePTFE), silks, polyester weaves and porousfilled materials.
 22. The valve of claim 19, wherein said counterrotating the first and second rotation mechanisms twists said tube toform a sealed tube.
 23. The valve of claim 19, wherein counter rotatingthe first and second rotation mechanisms twists said tube and forcessaid tube to collapse around at least one medical device inserted intosaid tube.
 24. The valve of claim 19, wherein said valve is a componentin a vascular introducer sheath.